NCT02319707

Brief Summary

To compare the efficacy of three different protocols of third stage management in preventing PPH.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Sep 2015

Shorter than P25 for phase_3

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 14, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 18, 2014

Completed
9 months until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

September 9, 2015

Status Verified

September 1, 2015

Enrollment Period

1.3 years

First QC Date

December 14, 2014

Last Update Submit

September 7, 2015

Conditions

Postpartum Hemorrhage

Outcome Measures

Primary Outcomes (1)

  • Change in Hemoglobin concentration during labor

    first and second day after delivery

Secondary Outcomes (1)

  • Blood count (CBC) on the first and second day after delivery

    first and second day after delivery

Study Arms (3)

Intramuscular treatment:IV

EXPERIMENTAL

pregnant women, 34-41 weeks of gestation, which were treated with 10 IU of IM Oxytocin during the third stage of labor.

Drug: Oxytocin

Combined treatment:IV+IM

EXPERIMENTAL

pregnant women, 34-41 weeks of gestation, which were treated with 10 IU of IM Oxytocin together with 10 IU of IV Oxytocin in 100 ml NaCl 0.9% during the third stage of labor.

Drug: Oxytocin

The control group

ACTIVE COMPARATOR

pregnant women, 34-41 weeks of gestation, which were treated with 10 IU of IV Oxytocin in 100 ml NaCl 0.9% during the third stage of labor. (this is the routine practice in our department).

Drug: Oxytocin in 100 ml NaCl 0.9%

Interventions

OxytocinDRUG

The study group: divided into two groups: • Intramuscular treatment: pregnant women, 34-41 weeks of gestation, which were treated with 10 IU of IM Oxytocin during the third stage of labor. • Combined treatment: pregnant women, 34-41 weeks of gestation, which were treated with 10 IU of IM Oxytocin together with 10 IU of IV Oxytocin in 100 ml NaCl 0.9% during the third stage of labor.

Also known as: Pitocin
Combined treatment:IV+IMIntramuscular treatment:IV
Oxytocin in 100 ml NaCl 0.9%DRUG

The control group: pregnant women, 34-41 weeks of gestation, which were treated with 10 IU of IV Oxytocin in 100 ml NaCl 0.9% during the third stage of labor. (this is the routine practice in our department).

The control group

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Singleton pregnancy.
  • weeks of gestation.
  • Maternal age between 18 and 45.

You may not qualify if:

  • Women who enter delivery room during the active phase of labor (cervical dilatation greater than 5 cm)
  • Coagulation defects
  • VAS score\>3 (pain score)
  • Women with early PPH
  • Suspected placental abruption

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Oladapo OT, Okusanya BO, Abalos E, Gallos ID, Papadopoulou A. Intravenous versus intramuscular prophylactic oxytocin for the third stage of labour. Cochrane Database Syst Rev. 2020 Nov 9;11(11):CD009332. doi: 10.1002/14651858.CD009332.pub4.

    PMID: 33169839DERIVED

MeSH Terms

Conditions

Postpartum Hemorrhage

Interventions

OxytocinSodium Chloride

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPuerperal DisordersUterine HemorrhageHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pituitary Hormones, PosteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and ProteinsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Yariv Yogev, professor

    Director, Division of obstetrics and delivery

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yariv Yogev, professor

CONTACT

9723-9377490yarivy@clalit.org.il

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Prof. Yariv Yogev Director, Division of obstetrics and delivery

Study Record Dates

First Submitted

December 14, 2014

First Posted

December 18, 2014

Study Start

September 1, 2015

Primary Completion

January 1, 2017

Study Completion

January 1, 2017

Last Updated

September 9, 2015

Record last verified: 2015-09